Senior Regulatory Affairs Specialist (Labelling)

Job summary

This role focuses on ensuring high-quality and compliant product information across multiple European markets within a collaborative labelling team. The position involves creating and maintaining product information, reviewing artwork, supporting Risk Management Plan updates, and monitoring European regulatory legislation.

Qualifications

• Degree in Pharmacy, Life Sciences, or a related field
• Over 5 years of experience in Regulatory Affairs, specifically in labelling and variations
• Fluent in English (written and spoken)
• Native-level proficiency in a Nordic language (preferably Finnish); additional languages are a plus
• Strong analytical, coordination, and problem-solving skills
• High level of accuracy with a GxP and business mindset
• Ability to thrive in a dynamic and fast-paced environment

Responsibilities

• Create and maintain product information (SmPCs, labelling, and patient leaflets) across various countries
• Review, proofread, and approve artwork and mock-ups
• Perform SmPC comparisons to ensure consistency
• Support updates to Risk Management Plans
• Update educational materials as needed
• Monitor and implement European regulatory legislation
• Collaborate with internal stakeholders and external authorities

Skills

• Proactive and detail-oriented
• Strong communication skills across functions and cultures
• Ability to work independently and as part of a team

Education

• Degree in Pharmacy, Life Sciences, or similar

Tools

• Familiarity with regulatory compliance tools and documentation processes